Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation

Logical Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LT-NS001; Drug: Naprosyn®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750243

LT-NS001-002

Details and patient eligibility

About

The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.

Enrollment: 120 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 18-30 kg/m2
• No NSAID's for 14 days prior to baseline endoscopy

Exclusion criteria

• Pregnant/Nursing women
• History of documented gastroduodenal ulcer

Trial design

120 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: LT-NS001

B

Active Comparator group

Treatment:

Drug: Naprosyn®